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Dropping ANZTPA joint regulatory agency a wise decision

Media Release

November 21, 2014

Dropping ANZTPA joint regulatory agency a wise decision

Dropping the proposed Australia New Zealand Therapeutic Products Agency (ANZTPA) is a wise decision, says the Medical Technology Association of New Zealand (MTANZ).

The Medical Technology Association of New Zealand (MTANZ) is the national association representing companies in the medical technology industry.

“We appreciate and support the decision that’s been made by both Governments. Our organisation could never support a joint regulatory agency that didn’t deliver benefits for New Zealand patients and the local economy in the long run,” comments MTANZ chief executive Faye Sumner.

Ms Sumner says that while her organisation respects the effort and planning that have gone into the ANZTPA process over the years, it could not see sufficient benefits to New Zealand from the proposed agency.

“New Zealand consumers and health boards could have seen increased healthcare costs and delayed access to innovative and life-saving medical devices if the ANZTPA had gone ahead as proposed.

“We totally support the need for medical devices in New Zealand to meet internationally-recognised standards for safety and performance and we look forward to working with Medsafe to achieve efficacy and safety standards that are appropriate for the New Zealand market.”

Ms Sumner says that over the past few years MTANZ has been advocating internationally for a globally-harmonised regulatory system so that companies do not have to meet multiple, and potentially conflicting, requirements or have to re-register devices in each country.

Currently, there are no compliance costs for offering a medical device for sale in New Zealand but companies do have to ‘notify’ their devices with the Government’s regulatory body, Medsafe before placing the device on the local market.

MTANZ proposes that the emphasis should be on improving post-market surveillance and utilising globally-accepted medical device market clearances to maintain public health and safety.

In a recent discussion document ANZTPA - A proposed regulatory framework for medical devices, MTANZ proposed five principles to guarantee timely access to safe medical technology while supporting industry innovation:

1. a regulatory scheme based on international best practice

2. a regulatory scheme that recognises third-party conformity assessment for all classes of medical devices

3. a regulatory scheme with a fee structure that is limited to efficiency costs only and fairly reflects the market size

4. a regulatory scheme that has a major focus on post-market vigilance and surveillance

5. a regulatory scheme that fosters and supports innovation and does not severely lengthen time to market.

“Our growing manufacturing medical device sector earned export revenues of around $642m last year and we would not like to see these manufacturers distracted from their main focus of developing and servicing new markets to be tied up in any duplicate regulatory process with unreasonable costs.

“Regulation must be balanced with the need to create an operating environment that fosters and supports innovation and clinical benefit.”

www.mtanz.org.nz

ends

The Medical Technology Association of New Zealand (MTANZ) is the national association representing companies in the medical technology industry. MTANZ aims to ensure the benefits of modern, innovative and reliable medical technology is delivered to the community for a healthier New Zealand.


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